As NPI engineer/ Quality engineer your objective will be to work with our multi-disciplinary science and engineering teams to provide independent verification and validation of the Company’s products during new product introduction and manufacturing.
The role is critical to the demonstration of compliance of product to international standards. This is an opportunity for an ingenious and inventive problem solver to provide invaluable assurance of the performance of Fluidic Analytics’ ground-breaking scientific instruments. It is a hands-on role requiring a statistical approach to problem solving.
Responsibilities and duties
- Plan verification and validation programmes, including interpretation and implementation of relevant standards, and establishment of acceptance criteria for assessing the performance of new products during product development and manufacture
- Design, develop and conduct verification and validation tests to demonstrate the performance of the company’s products at a system level.
- Perform analysis and interpretation of test data, including statistical analysis where necessary.
- Review requirements for traceability and testability.
Risk Management and Problem Solving
- Lead product design risk management activities using appropriate techniques (such as DFMEA, Fault Tree Analysis)
- Assist the project teams to solve design and development problems using root cause analysis and statistical techniques
- Supporting creation of Technical Files / Design History Files
- Contribute to the overall compliance of the Products, and identification of gaps (including documentation) to regulatory and the Quality System requirements.
- Take an active role in Design Reviews to assess quality and compliance.
Requirements of the candidate
- A degree in Engineering or related technical discipline with 3+ years experience of working in a product development environment covering the following areas:
- Conducting Device Risk Management, Design Verification and Validation activities
- Defining system test approaches incorporating software, electronics and mechanics
- Familiarity with working within ISO9001 Quality Systems
- Excellent communication skills and the ability to constructively critique the work of others to obtain the best product possible.
- Experience of working with a regulatory environment (such as medical device product development to ISO13485)
- Knowledge of statistical techniques (such as 6-Sigma)
Interested in Learning More?
Please send your CV and a covering letter to us at firstname.lastname@example.org and we will be in touch shortly.